ACTEON

United States

Model CAPT SOPIX² T2 USB2 CONDO · SOPRO

"""The SOPIX series digital X-ray imaging systems are intended to be used by a dental practitioner. The sensor (located in the patient’smouth just like a silver fi lm) captures the X-rays produced by the generator. Then it transmits this data to the computer to displaythe X-ray image on the screen.All the images captured with the SOPIX series system can be recalled onto the screen with the Sopro Imaging software provided withthe system. This software manages the display, processing and storage of images taken with the SOPIX series system.A.C.E™ (Automatic Control Exposure) technology, patented by SOPRO, provides the system with outstanding features. In real timeit analyses the quantity of energy received by the sensor, which fi xes the image acquisition once it has received the energy neededto produce a good-quality image. As a result, every image is protected against overexposure."""

DI: M430S80200051
Device class: Class II
Product codes
Submissions: K092329
Other identifiers: S_802_0005catalog number

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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances

510(k)K092329Substantially equivalent (SESE) · 2010-07-20clearance family

Predicate lineage

K092329
- K050693
- K050963

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2022-07-21	VAI	Voluntary action indicated	SOPRO	3

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